Method and device for the enhancement of topical treatments for oral mucositis and other oral conditions

A method of delivering a therapeutic agent to a portion of a mucosal tissue of a person, the method comprising:

• administering a therapeutically effective amount of the therapeutic agent;
• inserting, in a mouth of the person, a device comprising:
• an oral retention portion that is suitably shaped to be retained in an oral cavity for a predetermined treatment period and a covering portion that has at least one surface that contacts the mucosal tissue being treated with the therapeutic agent, and wherein the covering portion is further defined to have extending, from an exterior middle section of the device, ends positioned towards the back of the person's mouth, the exterior middle section of the device defining upper and lower middle section edges, the covering portion being further configured with extending upper wing portions positioned at each end and extending lower wing portions positioned at each end, and wherein both the upper wing portions and the lower wing portions having outer surface shapes that define uppermost wing surface edges and lowermost wing surface edges respectfully, and
• wherein each of the upper wing portions have an upper profile surface configured to include a first upper arcuate surface edge tapering upwardly from the upper middle section edges to the uppermost wing surface edge and the upper profile surface further configured to include a second upper arcuate surface edge tapering downwardly from the uppermost wing surface edge to the end of the fitting portion, and
• wherein each of the lower wing portions have a lower profile surface configured to include a first lower arcuate surface edge tapering downwardly from the lower middle section edges to the lowermost wing surface edge and the lower profile surface further configured to include a second lower arcuate surface edge tapering upwardly from the lowermost wing surface edge to the end of the fitting portion, and
• wherein the uppermost wing surface edge is positioned higher than the upper middle section edge of the device and the lowermost wing surface edge is positioned lower than the lower middle section edges of the device, such that the upper wing portions and lower wing portions covering at least a portion of mucosal tissue in the person's mouth, and
• wherein an upper bite flange and a lower bite flange extending from the interior surface of the fitting portion forming a bite wedge along each end of the fitting portion, and wherein each lower wing portion further includes a v-shaped notch being positioned adjacent each bite wedge towards the middle section such that wherein the lower surface edge along the middle section of the fitting portion extends arcuately towards each lower wing portion and the v-shaped notch defines a gap between the lower surface edge and a lower tab extending from the lower bite flange.

A kit for delivering a therapeutic agent to a mucosal tissue of a person, the kit comprising:

• a therapeutically effective amount of the therapeutic agent;
• a device, comprising:
• a fitting portion having an arcuate shape corresponding to the dental arche of the person, the fitting portion have an interior surface facing the person's teeth and an exterior surface facing the person's check and gums and the fitting portion further configured to have ends on either side of the arcuate shape, such that the ends of the fitting portion are positioned towards the person's back teeth, the exterior surface further defining a middle section positioned between the ends and configured to have a middle upper surface edge and a middle lower surface edge;
• an upper bite flange and a lower bite flange extending from the interior surface of the fitting portion forming a bite wedge along each end of the fitting portion;
• a covering portion extending from the exterior surface of the fitting portion, the covering portion extending toward each end of the fitting portion, the covering portion further having an upper wing portion positioned at each end of the fitting portion, and each upper wing portion having an upper profile surface configured to include a first upper arcuate surface edge tapering upwardly to an uppermost wing edge that extends to a position higher than the middle upper surface edge of the fitting portion, and the upper profile surface further configured to include a second upper arcuate surface edge tapering downwardly from the uppermost wing edge to the end of the fitting portion, and
• the covering portion further having a lower wing portion positioned at each end of the fitting portion, and each lower wing portion having a lower profile surface configured to include a first lower arcuate surface edge tapering downwardly to a lowermost wing edge that extends to a position lower than the middle lower surface edge of the fitting portion, and the lower profile surface further configured to include a second lower arcuate surface edge tapering upwardly from the lowermost wing edge to the end of the fitting portion, and
• wherein the upper wing portion and the lower wing portions having a defined outer surface shape to cover at least a portion of mucosal tissue of the person's mouth, and wherein the at least one covering section is more flexible than the fitting portion, and wherein each lower wing portion further includes a v-shaped notch being positioned adjacent each bite wedge towards the middle section such that wherein the lower surface edge along the middle section of the fitting portion extends arcuately towards each lower wing portion and the v-shaped notch defines a gap between the lower surface edge and a lower tab extending from the lower bite flange;
• and
• printed instructions on how to use the device to administer the therapeutic agent to the mucosal tissue of the person.